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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025319
Receipt No. R000028344
Scientific Title The study to investigate clnicopathological characteristics of superficial esophagogastro junction cancer
Date of disclosure of the study information 2016/12/19
Last modified on 2017/05/13

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Basic information
Public title The study to investigate clnicopathological characteristics of superficial esophagogastro junction cancer
Acronym EGJ_CA_Study
Scientific Title The study to investigate clnicopathological characteristics of superficial esophagogastro junction cancer
Scientific Title:Acronym EGJ_CA_Study
Region
Japan

Condition
Condition Esophagogastro junction cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify clinicaopthological characteristics of superficial esophagogastro junction cancer
Basic objectives2 Others
Basic objectives -Others Biocharacteristics
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Difference of clinicaopthological characteristics of superficial esophagogastro junction cancer according to presence and absence of endoscopic gastric corpus mucosal atrophy
Key secondary outcomes 1) Factors associated with endoscopic gastric corpus mucosal atrophy
2) Difference of clinicaopthological characteristics of superficial esophagogastro junction cancer according to presence and absence of Barrett mucosa
3) Difference of clinicaopthological characteristics between EGJ cancer and Barrett cancer
4) Difference of clinicaopthological characteristics between EGJ cancer and gastric cancer in the upper body.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Siewert type 2 cancer (true cardia cancer: adenocarcinoma located within 1 cm above and 2 cm below the GE Junction)
2) pathological T1
Key exclusion criteria 1) Unevaluable endoscopic images
2) Unevaluable histological findings
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noiya Uedo
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL 06-6972-1181
Email uedou-no@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Katayama
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email kbyori01@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design is a retrospective cross-sectional study.
Patients' data who treated in following Japanese institutions during 2010-2015 and met inclusion criteria were retrieved:
1) Cancer Institute Hospital of Japanese Foundation for Cancer Research, 2) Keio University Hospital, 3) Nagaoka Red Cross Hospital, 4) National Cancer Center Central Hospital, 5) National Cancer Center Hospital East, 6) Osaka Medical Center for Cancer and Cardiovascular Diseases, 7) Teine Keijinkai Hospital, 8) Tohoku University Hospital

Management information
Registered date
2016 Year 12 Month 18 Day
Last modified on
2017 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028344

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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